Foot dystonia is frequently observed in patients suffering from Parkinson'disease. It is characterized by an abnormal involuntary movement which is very uncomfortable (difficult to walk) and painful for the patient.

Botulinum toxin injections seem to be efficient to treat this dystonia. However studies on this topic are few and very imprecise (many muscle injected, especially the Flexor digitorum longus, different doses used, heterogeneous population with many types of dystonia included, open studies).

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

In a controlled double blind and randomized study, we want to show that intramuscular injections of botulinum toxin are beneficial to reduced dystonia and associated pain in patient with foot dystonia (compared to placebo injections). [ Time Frame: one month after the injection of botulinum toxin/placebo ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficiency comparison of injections made in leg muscle (Flexor digitorum longus) between injections made directly in foot muscle (Flexor digitorum brevis or quadratus plantae) - Effects of injections on pain and quality of life. [ Time Frame: one month after injections of placebo or Botulinum toxin ] [ Designated as safety issue: Yes ]

After an inclusion visit, patients are randomized in one of the 3 following groups :

First group (PL : placebo) :

J0 : Patient will receive 1 injection of placebo in the Flexor digitorum longus and 1 injection of placebo in the Flexor digitorum brevis or in the quadratus plantae

J+1month : First evaluation

J+3 months : Patient will receive again 1 injection of placebo in the Flexor digitorum longus and 1 injection of placebo in the Flexor digitorum brevis or in the quadratus plantae

J+4 months : Last evaluation

Second group (ME : Extrinsic muscle)

J0 : Patient will receive 1 injection of Botulinum toxin (100U) in the Flexor digitorum longus and 1 injection of placebo in the Flexor digitorum brevis or in the quadratus plantae

J+1 month : First evaluation

J+3 months : Patient will receive again 1 injection of Botulinum toxin (100U) in the Flexor digitorum longus and 1 injection of placebo in the Flexor digitorum brevis or in the quadratus plantae

J+4 months : Last evaluation

Third group (MI : Intrinsic muscle)

J0 : Patient will receive 1 injection of placebo in the Flexor digitorum longus and 1 injection of Botulinum toxin (100U) in the Flexor digitorum brevis or in the quadratus plantae

J+1 month : First evaluations

J+3 months : Patient will receive again 1 injection of placebo in the Flexor digitorum longus and 1 injection of Botulinum toxin (100U) in the Flexor digitorum brevis or in the quadratus plantae

J+4 months : Last evaluations

During injections (J0 and J+3M), we will measure the pain induced by injections (EVA) For each evaluation (J+1M and J+4M), following evaluations will be made: clinical improvement (CGI), dystonia evaluation (duration and severity, Burke scale), pain (EVA) and quality of life (PDQ39).

Eligibility

Ages Eligible for Study:

30 Years to 75 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age : 30-75 years

Patient with an idiopathic Parkinson's disease according to the criteria of the "Parkinson's Disease Society Brain Bank"

Patients never treated with botulinum toxin or already treated for more than 6 months.

Affiliation to social security

Agreement of patients

Exclusion Criteria:

Patients suffering of an atypical Parkinson syndrome

Patient with a bilateral tiptoe dystonia

Patients with contraindication to the botulinum toxin use

Women without efficient contraception

Person who participate to an other study

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909883